Handling Stress and Fatigue the Japanese Way

A new FOSHU category tackling stress and fatigue could be a reality in the near future.

By Ron Bailey

It is not surprising that stress is a major issue in Japan and has been for many years. For many, commuting to and from work is a major contributor to stress. Further, the Japanese often maintain long work hours and endure enormous pressure, partly as a result of the emphasis on a “customer-is-first” approach to business at all levels.

The Japanese even have a special word for “death from overwork” (karoshi), which is currently the subject of serious study. Suicide is the sixth leading cause of death in Japan, with annual deaths a-round 30,000 according to the Ministry of Health, Labor, and Welfare (MHLW). So what is being done to help the Japanese cope with their hectic lifestyles?

Government-Supported Initiatives

“Statistical Abstracts on Health and Welfare in Japan 2003” indicates that over 1.2 million Japanese were treated for mood, neurotic and stress-related disorders in 2002. Somewhat surprisingly, nearly two-thirds of those treated were women. Fatigue is listed as one of the top five categories for treatment of “persons with subjective symptoms,” following “low back pain” and “stiff shoulders” as the top two.

The MHLW has begun to use its annual national nutrition survey (National Nutrition Survey in Japan, 2002, and the National Nutrition Survey in Japan, 2003) to collect data on stress. In the 2002 survey, over 75% of males and over 80% of females reported having some level of stress in their daily lives. More than one-half of the population in all age groups (age 15 to over age 70) reported significant stress. Although the level of reported stress decreases somewhat in the retirement years, the numbers are still high enough to raise some eyebrows.

These national survey data on stress and fatigue have resulted in MHLW support for industry in the research and development of ingredients that can be shown in clinical studies to be helpful in preventing, or at least reducing daily stress. The purpose of this approach is to encourage an effort to formalize a health claim category for stress under the FOSHU (Foods for Specified Health Uses) regulatory umbrella. This approach will guarantee that sound science (including clinical studies and appropriate biomarkers) is in place to support new health claims for retail FOSHU products.

The initial approach has included defining the components of stress in Japan, as well as the stated reasons for daily stress. One important consequence of stress, and the first considered for FOSHU potential, relates to “anti-fatigue” health benefits. Several Japanese companies have been exploring functional ingredients that demonstrate anti-fatigue benefits in animal and clinical studies. And several companies are already marketing such products, without on-label health claims, but often with implied claims. Examples of ingredients that have emerged from preliminary anti-fatigue studies include:

• CoQ10
• L-carnitine
• Alpha lipoic acid
• Astaxanthin
• Oyster extract
• BCAAs (branched chain amino acids)
• Glutamine
• Milk peptide (PeptoPro)
• Anserine (from fish)
• Egg white peptide (Runpep)
• Soybean peptide

As one specific example, the popular functional ingredient CoQ10, as measured in the blood, is showing promise as a direct biomarker for fatigue. All of the fun-ctional ingredients in the list already have a history of safe food use in Japan, typically for other health conditions, which will be a positive when the anti-fatigue FOSHU category is eventually formalized. There are already unofficial estimates of a Japanese retail market potential for anti-fatigue products of $10 billion per year.

Japanese Company Consortium Activities

It is typical in Japan that a consortium of interested companies is assembled early in the development process in order to create a unified solution to a complex problem. This is often done with at least unofficial support and encouragement from MHLW. The FOSHU Anti-Fatigue project is one such example.

A Japanese organization, Soiken (www.-soiken.com), is the facilitator for the consortium, which includes nine pharmaceutical/chemical companies (Ohtsuka, Kao Corporation, Kaneka, Tanabe Seiyaku, Takeda Yakuhin, Taisho Seiyaku, Nisshin Pharma, etc.), seven food companies (Asahi Beer, ItoEn, Coca-Cola Asia Pacific, Dydo Drinko, Pokka Corporation, Meiji Dairies, Riken Vitamin), two trading companies (Mitsui Bussan and Mitsubishi Shoji), and five universities (Tokyo University, Osaka University, etc.). The consortium represents a very prestigious group of organizations that are already very active in the healthcare market in Japan.

The consortium was established to be in place for three years, starting in 2004.At the end of the full three years, the objective is to have developed sufficient scientific support to allow MHLW to formally expand the current FOSHU health claims categories to include anti-fatigue claims. MHLW has not expanded the allowed health claims categories since the development of the original FOSHU framework well over 10 years ago, so this is considered a major undertaking.

Current Market Activity in Japan

Until MHLW has formalized the Anti-Fatigue FOSHU category, Japanese companies can continue to market ingredients and products with promotional material claiming to help prevent fatigue, stress, and anxiety, and also to induce relaxation. One advantage of eventually having a formal FOSHU category with approved health claims is that it will allow MHLW to better control the range of claims in the re-tail market for both supplements and foods.

A quick review of the December 2006 issue of the Japanscan Food Industry Bulletin is enlightening in this regard. In the “Functional Food and Drinks” section, new products announced for introduction included:

• Chocolate with green tea theanine and theobromine for a relaxing effect
• Chocolate with GABA (gamma amino-butyric acid) for stress
• Beverage with vitamin C, theanine and GABA for stress
• Beverage with vitamin E, CoQ10, L-carnitine for stress
• Energy Drink with taurine, ginseng, amino acids, B vitamins, caffeine and herbs for recovery from muscle fatigue
• Amino Acid Supplement with amino acids for muscle fatigue.

All of these and other similar foods and beverages are regulated as foods in Japan, and are not allowed to make direct on-label health claims. However, a long history of safe consumer use of the functional ingredients will be a positive when decisions are made regarding the specific anti-fatigue FOSHU functional ingredients allowed. To that extent the marketing of such products is not discouraged; at least until the formal FOSHU category has been established.

Final Comments

Stress in daily life comes from many different sources, and is complicated to define in terms precise enough to allow the development of formal health claims. It is possible that the Anti-Fatigue FOSHU category will eventually be followed by others, but only in due course as experience is gained with the anti-fatigue functional ingredients. There are products on the market, for example, to help with the stress of “examination season,” which is a real issue for young Japanese students. There is stress related to stopping smoking, particularly amongst young married women of child-bearing age, which may require different functional ingredients. The market for stress-related products is broad enough, however, that there will be opportunities for years to come in Japan. Anti-Fatigue FOSHU products are just the first step. NW